News Briefs: Week of Jan. 17-21

FDA Warns of Severe Liver Injury Associated With Dronedarone

The FDA is alerting physicians and patients about cases of rare but severe liver injury in patients treated with the heart medication dronedarone, which is marketed as Multaq.

Dronedarone, which was approved by the FDA in 2009, is used to treat abnormal heart rhythms and reduces the risk of hospitalization associated with such heart problems. However, the agency said in a Jan. 14 safety announcement(www.fda.gov) that it has received several reports of hepatocellular liver injury and hepatic failure in patients treated with dronedarone, including two postmarketing reports of acute hepatic failure requiring transplantation.

The FDA said it is continuing to review safety data related to dronaderone and encouraged physicians and patients to report adverse events to the agency's MedWatch program(www.fda.gov).

Patients should not stop taking dronedarone unless told to do so by their physician.

Consider obtaining periodic hepatic serum enzymes, especially during the first six months of treatment.

If hepatic injury is suspected, dronedarone should be discontinued and serum liver enzymes and bilirubin testing should be performed. If hepatic injury is found, appropriate treatment should be initiated.

Dronedarone should not be restarted in patients who experience hepatic injury in the absence of another explanation for the liver injury.

Recalled Alcohol Prep Pads Packaged With Genentech Medications

Genentech Inc. is informing physicians and consumers that alcohol prep pads packaged and distributed with certain Genentech products were sourced from the Triad Group.

On Jan. 5, the Triad Group recalled all lots of its alcohol prep pads, swabs and swabsticks -- which are used to disinfect skin prior to injections or IV insertion -- because the products could expose patients to the pathogen Bacillus cereus.

Genentech, a member of the Roche Group, said the Triad Group's recalled alcohol prep pads are packaged with the following Genentech medications:

ibandronate sodium injection, which is marketed as Boniva;

enfuvirtide, which is marketed as Fuzeon;

somatropin, which is marketed as Nutropin A.Q. Pen;

peginterferon alfa-2a, which is marketed as Pegasys; and

tenecteplase, which is marketed as TNKase.

Genentech said in a Jan. 13 news release(www.fda.gov) that its medications are not contaminated, and they may continue to be used in accordance with the package insert. However, patients and health care providers should not use the alcohol prep pads packaged with these medicines and should instead use a pad that is not part of the Triad Group recall. Alternatively, a sterile gauze pad and isopropyl alcohol could be used to disinfect the injection site prior to administration.

"The company is initiating the recall as a precautionary measure after an extensive review of past production records found instances where equipment cleaning procedures were insufficient or that cleaning was not adequately documented," the company said. "It is very unlikely that this impacted the quality of these products."

McNeil also is recalling certain lots of Rolaids Multi-Symptom Berry Tablets -- also at the wholesale level -- because of a labeling issue. McNeil, which was subjected to a company-wide investigation by the FDA after numerous recalls last year, also recalled Rolaids in December because of wood and metal particles in the products.

McNeil said its most recent recalls were not undertaken on the basis of adverse events, and consumers can continue to use the affected products. Complete information about McNeil's recalls is available online(www.mcneilproductrecall.com).

CDC Finalizes Updated Tdap Recommendations

The CDC published updated recommendations(www.cdc.gov) for tetanus toxoid, reduced diphtheria toxoid and acellular pertussis, or Tdap, vaccine, in the Jan. 14 Morbidity and Mortality Weekly Report.

The CDC's Advisory Committee on Immunization Practices, or ACIP, recommends a single Tdap dose for people ages 11 through 18 years who have completed the recommended childhood series(5 page PDF) of diphtheria, tetanus and pertussis, or DTaP, vaccine, as well as for adults ages 19 through 64.

In addition to those already established recommendations, the ACIP recommended during its meeting in October 2010 that children ages 7 through 10 years who did not complete the recommended DTaP series receive a catch-up dose of Tdap.

In addition, the ACIP recommended during the October meeting that adults ages 65 and older who have close contact with infants receive a dose of Tdap. A dose also may be given to people in this age group who have not previously received Tdap.

The new recommendations also state that Tdap can be used regardless of the interval since previous immunization with a vaccine that contains tetanus or diphtheria toxoid.

Tdap vaccines Boostrix and Adacel both were licensed originally for use at an interval of at least five years.

Gender, Race, Income Can Determine Health, Says CDC Report

A new report(www.cdc.gov) from the CDC says demographic differences among Americans determine how likely people are to be healthy, to be sick or to die prematurely. According to a CDC press release(www.cdc.gov), the report highlights health disparities by gender, race and ethnicity, income, education, and disability status.

For example, the report says state level estimates in 2007 indicate that low-income residents have five to 11 fewer healthy days each month than do high-income residents.

Other findings in the report show that men are nearly four times more likely than women to commit suicide, adolescent birth rates among Hispanics and non-Hispanic blacks are as much as three times greater than those among whites, and the prevalence of binge drinking is greater among people with higher incomes.

The report addresses disparities at the national level and focuses on the conditions in which people are born, grow up, live and work.

'Not Sick,' Say Most Americans Without 'Usual' Source of Health Care

A research brief from the Agency for Healthcare Research and Quality says that one in five Americans lacked a consistent source of medical care in 2007.

According to the brief(www.meps.ahrq.gov), of the 20 percent of individuals who reported not having a "usual" source of care, 63 percent said the top reason was because they seldom or never became ill. The second most common reason cited was the high cost of health care.

Other top reasons reported included recent moves, problems finding a physician and issues with health insurance. Some people indicated that they did not use, trust or like physicians.

The scholarship aims to advance the progress of women in the medical profession and to identify and address the needs and interests of women physicians and medical students.

Proposals should focus on professional work or practice issues that affect women physicians, such as part-time working strategies, female physician practice patterns, burnout among women physicians and professional re-entry issues. Applications are due Feb. 15.